Off-patent Drugs Bill

Carolyn Harris Excerpts

Friday 6th November 2015 Commons Chamber

[Nick Thomas-Symonds (Torfaen) (Lab)]

I beg to move, That the Bill be now read a Second time.

It is an honour to be drawn in the ballot and to bring forward a private Member’s Bill on such a key issue. My grandmother, who inspired me to go into politics, died of breast cancer, and it is poignant for me that this Second Reading debate takes place in the week that would have been her birthday.

I am grateful to those who have sponsored this Bill, and to Members from across the House who have supported it. I thank the former hon. Member for Cardiff North, Jonathan Evans, whose Off-patent Drugs Bill was debated last year, and his successor, the hon. Member for Cardiff North (Craig Williams), for his support for this slightly refined version of the Bill. I thank my constituents for all their support, and I also thank Jenny Goodare from Breast Cancer Now for her help in preparing the Bill.

The Bill is a UK-wide Bill that creates a duty on the Government to make cheap drugs available when pharmaceutical companies have no incentive to do so. There is a problem: if a drug is shown to be useful for a new purpose after its original patent has expired, there is no financial incentive for a pharmaceutical company to sponsor that off-patent treatment through the processes that are normally used to licence it, and to ensure its adoption on the NHS.

Such off-patent treatments are usually available at low cost, but the current system is not set up to make them routinely available when they have been repurposed. Put simply, without a licence to act as a kitemark of safety, and a cost-effectiveness appraisal to give the NHS a mandate to provide it, there are multiple disincentives to treatments being prescribed, meaning that they are not routinely made available.

I have a letter from a clinician dated 15 October 2015 that I have permission to read out—the personal details have been redacted. He says he was contacted by a lady because she was advised that she had a high risk of breast cancer, and that raloxifene, which is an example of a drug that would benefit from the Bill, could be prescribed to help to prevent it. The key passage in the letter states:

“Unfortunately, I am unable to prescribe this as it is not licensed with this indication.”

[Interruption.] The Minister shakes his head, but I am quoting directly from a letter written by a clinician only in the past few weeks. That affects real people and has had a great impact on somebody’s life.

The Bill proposes a Government responsibility to step in and address that market failure in the public interest. Part 1 of the Bill introduces the duty of the Secretary of State to seek licences for off-patent drugs in new indications. The idea is to make those cheap, off-patent drugs routinely available. The president of the Royal College of Surgeons of Edinburgh recently said that, at the moment, there is significant variation, leading to variation of access across the UK.

There are barriers to the drugs being regularly available. Lack of awareness is a problem, but it is not all about that. General Medical Council guidance states that licensed treatment should be considered before an off-label or unlicensed treatment. In addition, GMC guidance is clear that a doctor takes on an extra level of personal liability when prescribing off-label.

[Carolyn Harris (Swansea East) (Lab)]

A Government spokesman was quoted in The Independent this week saying that the only thing general practitioners need is more information. Does my hon. Friend agree that that was both unhelpful and ill-informed? Deluging GPs with yet more information is certainly not productive.

[Nick Thomas-Symonds]

My point is precisely that it is about more than information.

A licence for off-patent drugs would make a big difference. The all-party parliamentary group on off-patent drugs, which I chair, met on 15 October and took evidence from experts across the board. Pan Pantziarka, a repurposing specialist, said that granting a new licence triggers a “whole cascade of things”: the British National Formulary gets updated, clinical commissioning groups and specialist bodies take note, and guidance is updated. He said that, without that, we are dependent on doctors reading the literature and prescribing off-label, and that that is not the solution we want.

Sir John Burn, professor of clinical genetics and a non-executive director of NHS England told our inquiry:

“The other problem is making decisions in a short time scale—we haven’t got time to look at the bundle of evidence presented. The whole point of the licensing process is to distil that for the physician”